May 23, 2023
GPSR introduces major changes to product safety regulations for manufacturers, importers, and distributors operating in the EU
The much anticipated EU General Product Safety Regulation (GPSR) (Regulation (EU) 2023/988) has now been formally published in the Official Journal of the European Union. GPSR replaces the 20-year-old General Product Safety Directive (GPSD), substantially changing the safety requirements for general products sold in the EU market that broadly fall outside of harmonized regulations (i.e., non-CE marked products).
Safety considerations for products that are not controlled under other regulations may also fall under GPSR requirements. For example, chemical and biological risks associated with food contact materials and articles are addressed by framework Regulation (EC) No 1935/2004; however, physical risks associated with these materials and articles are not addressed per se and so could be considered now to fall under this GPSR.
Manufacturers, importers, and distributors need to be vigilant about new requirements that may apply to the various products they place in the EU market, such as requirements regarding the physical risks of packaging or the safety of promotional items and accessories.
Key changes under GPSR
Some key changes under GPSR include the following:
- All products placed on the EU market that fall under GPSR must have an "internal risk analysis" and an up-to-date technical file "containing at least a general description of the product and its essential characteristics relevant for assessing its safety." The technical document may also need some of the following (depending on the risks related to the product):
- An analysis of risks and risk control measures, including the reports of any testing carried out.
- A list of standards, or sections of standards, complied with.
- Consideration of cybersecurity risks.
- Risk of a product being inadvertently used as a food or toy due to its appearance.
- Interaction with other products.
- Documentation of procedures in place to ensure continued conformity of products.
- Traceability of products through labelling or identification.
- Companies that are not economic operators within the EU must establish a responsible person in the EU to import products.
- GPSR requirements apply to "second-hand products or products that are repaired, reconditioned or recycled that re-enter the supply chain in the course of a commercial activity."
- Increased traceability requirements may apply to certain products, groups, or categories of products and relevant supply chains that are "likely to present a serious risk to health and safety of consumers."
- Manufacturers with reason to believe a product they have on the market is dangerous must take immediate corrective measures/actions, inform consumers, and inform the market surveillance authorities.
Some other general changes introduced under GPSR include the following:
- Increased enforcement requirements and activities.
- New rules and requirements for online marketplaces.
- Rules around digital modification of products where this may impact product safety.
- New requirements to report potentially unsafe products on Safety Gate.
- Allowances for e-labelling to be used to supply additional product information.
This raft of changes to product safety regulations in the EU market may impose considerable new requirements on manufacturers, importers, and distributors. GPSR comes into effect 20 days after its publication date. It will apply fully from December 13, 2024, and will be directly applicable in all EU Member States.
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